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ID

26551

Descrição

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

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Versões (1)
  1. 18/10/2017 18/10/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

18 de outubro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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    study conclusion Ropinirole CR Ropinirole IR Monotherapy 101468/168

    Inglês

    study conclusion Ropinirole CR Ropinirole IR Monotherapy 101468/168

    1 Formulários  
    Administrative Data
    Descrição

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Descrição

    subject number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2348585
    STUDY CONCLUSION
    Descrição

    STUDY CONCLUSION

    Date of subject completion or withdrawal
    Descrição

    Date of subject completion or withdrawal

    Tipo de dados

    date

    Did the subject withdraw from study as a result of this AE?
    Descrição

    Withdrawal

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1710677
    UMLS CUI [1,2]
    C1518404
    Primary reason for withdrawal
    Descrição

    Primary reason for withdrawal

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    Other, specify
    Descrição

    Other primary reason for withdrawal

    Tipo de dados

    text

    PREGNANCY INFORMATION
    Descrição

    PREGNANCY INFORMATION

    Did the subject become pregnant during the study?
    Descrição

    If Yes, complete Pregnancy Notification form.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0008976
    OVERALL COMPLIANCE
    Descrição

    OVERALL COMPLIANCE

    Did the subject generally take their morning dose of medication within 2 hours of a meal?
    Descrição

    Overall compliance

    Tipo de dados

    boolean

    INVESTIGATOR’S SIGNATURE
    Descrição

    INVESTIGATOR’S SIGNATURE

    Investigator’s Signature
    Descrição

    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator’s name (print)
    Descrição

    InvestigatorName

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0035173
    UMLS CUI [1,2]
    C0600091
    UMLS CUI [1,3]
    C1547383
    Date
    Descrição

    Investigator Signature Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Voltar ao início da página

    Similar models

    study conclusion Ropinirole CR Ropinirole IR Monotherapy 101468/168

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    subject number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    STUDY CONCLUSION
    Date of subject completion or withdrawal
    Item
    Date of subject completion or withdrawal
    date
    Item
    Did the subject withdraw from study as a result of this AE?
    text
    C1710677 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Withdrawal
    Code List
    Did the subject withdraw from study as a result of this AE?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Primary reason for withdrawal
    text
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Primary reason for withdrawal
    Code List
    Primary reason for withdrawal
    CL Item
    Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Events forms as appropriate) (1)
    CL Item
    Lost to follow-up (2)
    CL Item
    Protocol violation (3)
    CL Item
    Subject decided to withdraw from the study (4)
    CL Item
    Lack of efficacy (5)
    CL Item
    Sponsor terminated study (6)
    CL Item
    Non-compliance (17)
    CL Item
    Other (Z)
    Other primary reason for withdrawal
    Item
    Other, specify
    text
    Item Group
    PREGNANCY INFORMATION
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    pregnancy during study
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Not applicable (Not of childbearing potential or male) (Not applicable)
    Item Group
    OVERALL COMPLIANCE
    Overall compliance
    Item
    Did the subject generally take their morning dose of medication within 2 hours of a meal?
    boolean
    Item Group
    INVESTIGATOR’S SIGNATURE
    Investigator Signature
    Item
    Investigator’s Signature
    text
    C2346576 (UMLS CUI [1])
    InvestigatorName
    Item
    Investigator’s name (print)
    text
    C0035173 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    C1547383 (UMLS CUI [1,3])
    Investigator Signature Date
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Voltar ao início da página 

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